In this study, we want to learn more about a new drug called iptacopan to see if it can help treat a rare kidney disease called IC-MPGN (immune complex mediated membranoproliferative glomerulonephritis).
We are comparing how iptacopan (taken by mouth) works compared to a placebo. A placebo looks the same and is given the same way as iptacopan but has no active parts. The study has two parts. In the first part, you/your child will be randomly assigned to take either iptacopan or a placebo, like flipping a coin. In part two, everyone in the study will take iptacopan. If you/your child joins this study, you will come to 12 visits at Children’s Hospital Colorado over the course of 15 months. At these visits, we will do a brief physical exam and ask you questions about your health. We will use a needle in your arm to collect blood samples. We will also ask you to give urine samples. We will do tests to learn about the function of your heart. We may also do a kidney biopsy to make sure you are able to join this study. If you complete all visits in this study, you will be paid up to $1,430.
You/your child may be able to join this study if you are between 12 and 60 years old and have a diagnosis of IC-MPGN. If you are interested in joining our study, we will do other tests to make sure you meet other requirements and that it is safe for you to join.
Protocol Number: 23-0839
More information available at ClinicalTrials.gov: NCT05755386
Principal Investigator